iStar How to start a new Protocol

1. iStarHow to start a new Protocol iStar Basics Training Course For Investigators http://istartraining-chla.usc.edu

2. What You Will Learn • Site navigation • Creating application for new studies • Using SmartForms • Different types of questions • Prerequisites for submission • The application review process • Where to get help

3. Program Overview • Web application • Multiple browser support • Limited Macintosh support (not Safari) • Secure environment • Username and Password required • SQL database on server • Central storage for all data • All users see the same version

4. Obtain iStar account • For CHLA users:Please contact the main phone number: 323-361-2265 • For UPC and HSC users:Obtaining an iStar Account - follow steps below • Put   iStar Account Request   in the subject line of an email. • Include the following in the body of the email: • Last, First (Middle)  - please provide your name in this order • campus* • division and department (be specific) - if you are not sure, please provide a PI or Faculty Advisor of the study that you will be a participant of. • email address • user role** • phone number  • Send the email to istar@usc.edu. • You may include more than one persons request in the same email.  Within one business day, you will receive an email with your user name and temporary password.  Use this information to login to you iStar account. • * Specify campus as either USC - Health Sciences, USC - University Park, or CHLA - Childrens Hospital LA.** Some of the user roles are Faculty Advisor, PI/Staff and etc...

5. Sites • iStar website • https://istar-chla.usc.edu • Must obtain iStar account to start a study or participate in the study • iStar Training (Sandbox) website • http://istartraining-chla.usc.edu • Training usernames are provided on the website

6. Training Site Location http://istartraining-chla.usc.edu/ Username: pi1-chla, pi2-chla, pi3-chla pi1-hsc, pi2-hsc, pi3-hsc pi1-upc, pi3-upc, pi3-upc Password: 1234

7. Personal Folder Breadcrumb Navigator Header Top Navigator Bar New Study Button Tabbed Area

8. Types of Questions in iStar TEXT BOX YES/NO RADIO BUTTON VS. SELECT ONE (radio button) VS. MULTIPLE THINGS (check boxes)

9. Types of Questions in iStar (cont’d) DROP-DOWN SELECTION VS. SINGLE VS. MULTIPLE PERSON SELECTION FILE ATTACHMENT

10. Single Person Selection

11. Multiple Person Selection

12. Attaching a Document (.doc; .xls) Document must be saved on your desktop, floppy disk or somewhere on the computer for you to upload it into iStar!

13. Study Workspace Summary Panel Tabbed Area Left-hand column

14. Validation Check SmartForm Progress Hide/Show errors Also on Submit Activity

15. Use SmartForm Progress

17. Submitting the Study • Submission Instructions • Send Study Ready Notification • All Co-Investigators must agree to participate • Principal Investigator is required to execute the submit activity (CCI, UP or HS) • Anyone on the study team can respond to change requests • When the study is submitted, a new ID number will be assigned. This new ID number will be the official IRB Study number.

18. Routing and Review • Routing is based on questions and actions • Activities might change depends on the Study State • Email notifications sent to study team • All actions and correspondence are logged • Approval letter and approved consent forms are posted in the study folder • You must have Human Subjects Certification to participate in the Study.

19. Responding to Contingencies • Study team will receive email notification • View the correspondence in the history log • Anyone on study team can edit the application • Respond to contingencies • Make necessary changes to the study • Copy-and-paste contingency list from the letter into the response text box • Under each contingency item explain what you did • Any study team member may submit the response

20. Study Approval • Study team will receive email notification • The approval letter appears in the summary panel and history log • Approved consent forms in Documents tab • Tabbed area has Amendments, Continuing Reviews, Reportable Events and Documents • Left-hand side has create buttons for RE’s, AM’s, and CR’s

21. iStar shortcuts Select ‘Jump To’ to jump to different SmartForm page when updating the study, amendment, continuing review or adverse event Select the page you need to update. When you finish with changes, you can click on ‘Save’ and then ‘Exit’ (on the gray menu bar) to get back to the workspace.

22. iStar shortcuts cont’d To check the status of your study or AM or CR or AE when it is not in your inbox, select ‘Studies’ on Top Navigator Bar (black header) Your study will appear under ‘In Progress’ or ‘Approved’ tabs. If you forgot the whole title of your study and don’t remember the Study#, you can type in partial title with % in front or after the partial title. Example: Full title – ‘Drug and Medicine Abuse’. In the text box next to ‘Go’, you can type the following: %medicine% All studies with word medicine in the title will be available for you. % - wild card

23. Production Information • Official Site: http://istar-chla.usc.edu • Mandatory Use for all New Studies

24. Training Resources • All resources found under Training Resources • Application Questions • User Guide for Investigators • Information “Quick” Sheets • “Sandbox” Mode (Training Site)

25. Where To Get Help • IRB Office: Content questions • Technical Support: Yana Gorelik – iStar Technical Support istar@usc.edu (323) 276-2238 Martin Koning Bastiaan - iStar Director martin.kb@usc.edu (323) 276-2232 • We welcome all Questions & Comments